A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

NCT ID: NCT00462345

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-07-31

Brief Summary

This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab, Methotrexate

Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate greater than or equal to (≥) 5 mg/week, PO, folate greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.

Group Type: EXPERIMENTAL

rituximab

Intervention Type: DRUG

1000 mg i.v. on Days 1 and 15

Methotrexate

Intervention Type: DRUG

10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24

Corticosteroid or NSAID

Intervention Type: DRUG

≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24

Folate

Intervention Type: DIETARY_SUPPLEMENT

≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24

Interventions

rituximab

1000 mg i.v. on Days 1 and 15

Intervention Type: DRUG

Methotrexate

10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24

Intervention Type: DRUG

Corticosteroid or NSAID

≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24

Intervention Type: DRUG

Folate

≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MabThera; Rituxan

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-80 years of age;
• rheumatoid arthritis for >=6 months;
• receiving outpatient treatment;
• an inadequate response to at least one anti-TNF therapy;
• stable methotrexate for >=12 weeks.

Exclusion Criteria

• other rheumatic autoimmune disease or inflammatory joint disease;
• previous treatment with MabThera;
• concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Countries

South Korea

References

Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

Reference Type: DERIVED

PMID: 27889300 (View on PubMed)

Other Identifiers

ML20934

Identifier Type: -

Identifier Source: org_study_id